Lead Regulatory Strategist (f/d/m)

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives - and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Lead Regulatory Strategist is responsible for providing regulatory strategy expertise to diverse Cytiva product teams, including chemical/materials requirements and Chemistry, Manufacturing, and Controls (CMC), IMPD, and eCTD Module 3 content, review and strategy relevant to Cytiva products and their applications.

This position reports to the Manager of Regulatory Science and Strategy and is part of the Cytiva global QA/RA team with this position located in Cologne and will be an on-site role.

What you will do:

• Provide regulatory guidance to relevant stakeholders on regulatory requirements, development programs, and compliance considerations throughout the product lifecycle. Knowledge of cell line technologies for viral vector production is preferred.

• Develop and implement regulatory strategies and roadmaps for Cytiva products and development programs, including cell line technologies for viral vector production, genomic medicines (cell and gene therapies), equipment, and other strategic innovation projects.
• Author, review and approve regulatory dossiers and communications in a global regulatory setting, including preparing eCTD-ready documentation for regulatory filings.
• Accountable for developing the Health Authority engagement and interaction plans for their assigned products, including the authoring of the regulatory communications and briefing documents, leading the team through meeting preparations and moderating the meeting itself.
• Support customer-facing regulatory inquiries by providing clear, compliant, and scientifically grounded guidance on product use, regulatory documentation, CMC expectations, and health authority requirements.

Who you are:

• MS/MEng degree or higher from an accredited institution; PhD or MD preferred.
• Minimum of 10 years of experience working with global regulatory agencies and health authorities, including the US FDA, EMA/Competent Authorities, and other global regions. Experience with Good Manufacturing Practices (GMP) for biologic drug development and significant Chemistry, Manufacturing, and Controls (CMC) and/or ICH Module 3 experience required; cell therapy and/or gene therapy CMC experience preferred.
• Proficient in Microsoft Office applications, including Word, Excel, and PowerPoint, with the ability to work effectively in electronic document management systems; experience with Veeva Vault is a plus.
• Strong communication, interpersonal, and problem-solving skills; skilled influencer with the ability to communicate complex messages clearly. Excellent written and verbal communication skills, with fluency in English.
• Acts as a strong regulatory business partner who can engage effectively in a diverse, cross-functional matrix environment to develop regulatory strategy and drive deliverables.

It would be a plus if you also possess previous experience in:

• Regulatory support for cell line technologies for viral vector production.
• Regulatory support for advanced therapy development.

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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.